T he FDA other judicial or regulatory body's decisions in this area (known as "federal preemption doctrine") is a contentious one, made more so by a recent US Supreme Court decision that has left the field open for individual state actions. Likewise, the May 2009 issuance of a Draft Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion has raised important questions about the future regulation of pharmaceutical communications. Citing the factors and social science background that it currently uses to assess communications from its regulatory perspective, FDA has requested comments from the regulated industries and the public. As of this writing, the deadline for submission of comments has not been reached, and further disposition of the Draft Guidance is unknown. Communications from the pharmaceutical industry about its products are subject to the laws and regulations affecting promotion of prescription drugs that are contained in two primary documents: the US Federal Food, Drug and Cosmetic Act ("the FD&C Act"), and the Code of Federal Regulations Title 21 ("the Code"). In addition, certain aspects of promotion are governed by subsequent documents and commentaries, such as Notices appearing in the Federal Register, FDA Guidance Documents, and FDA Untitled Letters (formerly called Notice of Violation or NOV) and Warning Letters. Violations of various sections of the Act are punishable by both imprisonment and fines, and FDA also has broad remedial authority to correct misleading promotion. Some Basics About Promotion Communications regulations are issued by FDA to provide assurance to physicians, other healthcare professionals, and, increasingly, the public, that the ACKNOWLEDGMENTS During the period covered by Medicine Ave 2, the Healthcare Communication & Marketing Association (HCMA), and its predecessor the HMC Council, provided support for the development of a three-volume workbook set: "Understanding Promotional and Educational Regulations/Guidelines for Prescription Drugs: A Training Program." I am particularly grateful to HCMA for permission to quote extensively from Volume III (Workbook) which I prepared with two colleagues. Special acknowledgements go to Alan Bennett, Esq. of the law firm Ropes & Gray, and to Lloyd Millstein, former Director of the FDA Division of Drug Marketing, Advertising and Communication (DDMAC). 53
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